Hospira is taking a quality by design-oriented approach to compliance remediation and quality improvement at its key Rocky Mount, North Carolina injectable manufacturing facility – focusing more heavily on identifying and monitoring critical process steps than on reviewing batch records.

The different tact that Hospira is taking in its compliance remediation efforts reflects the challenge of keeping its operations going at the Rocky Mount plant while overhauling its quality management program.

The extent of the FDA concerns at the plant, expressed in lengthy 483s over the past few years and underscored in a warning letter in April, 2010would typically have resulted in a plant closing, potentially under a consent decree, until the remediation could be assured by the agency.

However, the role Hospira plays in supplying medically necessary injectables and the threat to the healthcare system if that supply were disrupted has lead the agency to work with the company in achieving the overhaul while production continues.